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UAB marijuana oil study still awaiting FDA approval

Dustin Chandler of Pelham speaks about a law that was passed that could help his daughter deal with a rare genetic disorder that causes seizures during legislative orientation on Tuesday, Dec. 9, 2014, in Montgomery, Ala.(Photo: Albert Cesare / Advertiser)Buy Photo

Months after it won authorization from the Alabama Legislature, the University of Alabama Birmingham is still waiting word from the Food and Drug Administration on whether it can begin research on an oil derived from marijuana and its effect controlling seizures.

Dustin Chandler, a Pelham police officer who pushed for a state law authorizing the study in the hopes the oil would bring his daughter’s seizures under control, said Tuesday the FDA had yet to send a letter to UAB authorizing the program.

“It’s sad to me,” Chandler said after speaking to new members of the Alabama House Tuesday. “It’s been over 80 days that this letter has not been sent. And we’ve got children and adults suffering in Alabama.”

The law, signed by Gov. Robert Bentley in April, would allow UAB to conduct a research study into the health effects of cannabidiol, also known as CBD. The substance is derived from the marijuana plant, but has very little THC, the substance in marijuana that creates highs. The substance may help control pain and seizures. CBD can be purchased legally in four western states.

Chandler’s daughter, Carly, is three years old and suffers from a rare genetic disorder that can cause up to 200 seizures a day. The law authorizing the study was named after her.

“I was saying a prayer over my daughter’s bed because she was in the middle of a 10-minute seizure,” Chandler told lawmakers gathered for legislative orientation. “I took video of it, to spread it and let (people) know how serious an issue that is.”

The Legislature provided $1 million to UAB to fund the five-year study. Participants will not be criminally liable for possession of CBD.

Both Chandler and Bob Shepard, a spokesman for UAB, said Tuesday that the FDA had told UAB that they expected to send a letter shortly.

“It’s been several weeks they’ve been saying ‘you should have it in a week,’” Shepard said.

A message left with the FDA was not immediately returned Tuesday afternoon. UAB has sent the FDA information on what protocols it would follow in conducting the research; the FDA’s letter would either extend approval, disapproval or suggest changes. Shepard said after receipt of a letter giving approval to the program, other entities, including the Drug Enforcement Administration, would have to be notified, but that it “should be a quick process” to start the study.

Chandler said he was hopeful that the oil could have a positive effect on her daughter’s condition.

“It’s not a guarantee, (but) we hope it reduces the number of seizures,” he said.

Chandler was part of a presentation organized by House Speaker Mike Hubbard, R-Auburn, to illustrate the positive impact legislation passed by the Alabama Legislature could have.

“My daughter cannot walk, cannot talk and the likelihood of her doing that is very slim,” Chandler told the members gathered in the House chamber. “Though she can’t walk and talk, she is the future of Alabama . . . you guys can impact the future of Alabama by listening to the constituents who put you here.”